Back to Basics: GDPs & Reducing Regulatory Risk (1 of 2)

What are GDPs? Why do they matter?

Good Documentation Practices are standards by which data quality and integrity are ensured. GDP can be summed up like this: If you didn’t record it, you didn’t do it! 
This is a basic element of current Good Manufacturing Practices (cGMPs). Even though it may not be written explicitly in the Quality System Regulations (FDA 21CFR820), GDPs are most definitely a part of FDA's audits! 


Here are a few FDA audit observations that refer to GDP deficiencies identified during audits:

• Audit observation due to changes to data not dated: US FDA Form FDA 483 Observation #9A
• Warning letter specifically referring to inaccurate, incomplete and altered laboratory data, including original data being obscured and use of pencil to record data  US FDA "Warning Letter" 320-01-02
• Warning letter addressing use of correction tape, erasures and write-overs of data  US FDA "Warning Letter" to Simmons Pet Food 23-Jul-08, Observation #13b.

As you can see, Adherence to GDPs is critical to reducing your regulatory risk! GDPs are straightforward and easy to follow. This is one of the easiest ways to limit your risk of observations during an audit!

The basic tenets of GDPs can be summed up in the acronym ALCOA:

• Attributable: 
• Data must be linked to its source (equipment name, study name, patient identifier, etc) and to the individual(s) who observed and recorded the activity. If one person observed and another recorded the data, then data must be attributed to both persons. 
• If any changes are made, the individual making the changes must be clearly identified as well.
• Per FDA regulation  21CFR58.130, "All data entries shall be dated on the date of entry and signed or initialed by the person entering the data...  In automated data collection systems, the individual responsible for direct data input shall be identified at the time of data input".
• Legible: 
• If data cannot be read, then it cannot be utilized! Entries must be written clearly, with permanent ink.
• Changes to data cannot obscure the original entry - legibility applies to errors as well!
• Per FDA regulation  21CFR58.130, "Any change in entries shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or identified at the time of the change".
• Legibility requirements apply to electronic data as well. Per 21CFR11.10 (b), " The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency." Also in  21CFR11.10 (e), "Record changes shall not obscure previously recorded information."
• Contemporaneous:
• Data is to be recorded at time observation is made - contemporaneous with the observation.
• No back-dating! 
• Per FDA regulations 21CFR11.10 (e) "All data generated ...shall be recorded directly, promptly, and legibly in ink. All data entries shall be dated on the date of entry and signed or initialed by the person entering the data."
• Original:
• First record of observation is most accurate and reliable recording of data. 
• Also known as source data or raw data
• FDA regulations 21CFR11.10 and 21CFR58.130 apply as well
• Accurate:
• Free from errors
• Data recorded as is, no modifications or falsification
• FDA regulations  21CFR11.10 and 21CFR58.130 apply as well

Even though regulatory focus of this blog entry has been on the FDA, the EU also has a guidance document on GDPs with many similar requirements:

• EU Guidance Document guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in Directive 2003/94/EC for medicinal products for human use and Directive 91/412/EEC for veterinary use.

Stick around for part 2 of this blog entry on Friday June 22 to get a GDP checklist you can use today!